Retinal prosthetic company Second Sight Medical ($EYES) made a huge splash late last month with a NASDAQ IPO that had one of the biggest first day performances of any IPO this year at 122%. The startup, which has an FDA-approved retinal implant to improve vision in patients who have lost it due to retinitis pigmentosa (RP), has since settled into a respectable 56% gain.
 |
| A woman with Pixium's retinal implant wearing glasses with an integrated camera--Screenshot courtesy of Pixium |
Now competitor Pixium Vision ($PIX), which had its own IPO on Euronext Paris in June that raised $53.4 million, is ready to head to European regulators with a similar product candidate.
It expects to file as early as this month for European regulatory approval of its Iris retina implant device, according to a Bloomberg article. The company expects it could receive a CE mark by June.
It's also planning to double the number of patients testing the implants to 10 by March, in order to generate sufficient data to enable reimbursement in EU countries. Three companies already have gained European reimbursement for devices that restore some vision to blind patients including German-based Retina Implant and Second Sight, according to the story.
"Our retinal implant will bring a significant difference to the patient," Pixium chairman Bernard Gilly told Bloomberg. "There's room for two players, probably three, in this market, as is the case for cochlear implants."
Pixium's Iris System, like Second Sight's, is for the restoration of some vision for people who have lost eye sight due to RP. It uses an epi-retinal implant with 50 electrodes that connects to a "pocket computer" that connects to a pair of glasses with an integrated camera. The system allows users to perceive light and shapes to better navigate unfamiliar environments. Second Sight's currently marketed implant has 60 electrodes.
The French startup plans to commercialize a more sensitive, 150-electrode version of Iris next year--which could be sufficient for the blind to read and recognize faces. Pixium is also working on Prima VRS, which uses a sub-retinal implant and it anticipates will better enable vision. It expects to start clinical trials in Europe on the Prima VRS in 2016.
The Pixium device requires less energy than that for Second Sight, but the latter has more electrodes, providing better resolution and adjustable software, the Bloomberg article said. It added that payers in France and Germany are reimbursing about €100,000 euros each for the Second Sight system.
Gilly expects Pixium to gain more traction in the stock market once it can demonstrate insurance coverage that's similar to that for Second Sight's product. It's shares have declined about 17% from the IPO price this summer.
- here is the Bloomberg story